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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72991

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 15, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.

Z-1244-2016
Recall number
Z-1244-2016
Initiated
December 15, 2015
Classification
Class II
Status
Terminated
Quantity
25 devices (4 domestically in U.S.A. and 21 internationally)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditions.

Code information

Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927 and 203929.

Distribution pattern

Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.

Field note

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